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Humira Level

my little penguin

Moderator
Staff member
Adalimumab Level for IBD - The American Gastroenterological Association recommends optimal adalimumab trough concentration of 7.5 mcg/mL or greater in patients with active IBD. Data from separate clinical studies suggest an optimal adalimumab trough concentration greater than 4.5 mcg/mL or 8-12 mcg/mL. Sub-therapeutic adalimumab levels may be due to a patient not yet achieving a steady state trough level early in therapy, inadequate dosing, a dosing interval that is too long or accelerated adalimumab clearance. Accelerated adalimumab clearance may be explained by the presence of adalimumab anti-drug antibody or rheumatoid factor in the patient's serum, or may be caused by other diseases that indirectly lead to immunoglobulin loss (i.e. kidney disease, protein-losing gastroenteropathy). If the steady state trough adalimumab level is low despite adequate dosing, adalimumab anti-drug antibody testing should be considered.
from

 

my little penguin

Moderator
Staff member
Abstract
Background: Adalimumab is an established treatment for Crohn's disease. Limited data are available regarding the relationship between adalimumab drug levels and serum/fecal markers of gut inflammation. We therefore aimed to characterize the relationship between adalimumab levels and biologic remission during maintenance therapy.
Methods: A single-center prospective cross-sectional study was undertaken on Crohn's disease patients who had received adalimumab therapy for a minimum of 12 weeks after induction. Data on clinical activity (Harvey-Bradshaw Index), C-reactive protein (CRP), adalimumab drug and antibody levels, and fecal calprotectin were collected. Biologic remission was defined as a CRP <5 mg/L and fecal calprotectin <250 µg/g. Adalimumab drug and antibody levels were processed using the Immundiagnostik monitor enzyme-linked immunosorbent assay.
Results: One hundred fifty-two patients had drug and antibody samples matched with CRP and fecal calprotectin. Patients in biologic remission had significantly higher adalimumab levels compared with others (12.0 µg/mL vs 8.0 µg/mL, P < 0.0001). Receiver operating characteristic curve analysis demonstrated an optimal adalimumab level of >8.5 µg/mL (sensitivity, 82.2%; specificity, 55.7%; likelihood ratio, 1.9) for predicting biologic remission. Multivariable logistic regression revealed that adalimumab levels >8.5 µg/mL were independently associated with biologic remission (odds ratio, 5.27; 95% confidence interval, 2.43-11.44; P < 0.0001).
Conclusions: Higher adalimumab levels are associated with biologic remission. An optimal level of >8.5 µg/mL was identified.

From
 
We haven’t talked to the GI yet since it’s late in the evening, but it seems that 5.13 is a little low. He gets Humira every 2 weeks, so I wonder if he would benefit from more frequent injections…? Thoughts on a level of 5.13??
 

my little penguin

Moderator
Staff member
The two reports I posted stated 7.5 or 8.5 is needed .
Depends on antibodies as well
Did it show antibodies to humira ???
Adding mtx boosts humira , as does weekly doses
Sometimes they add all three things at once (mtx, higher humira at weekly doses and een )
Then hope for the best
Later once in remission dropping things off
 
Last time we talked to the GI, she mentioned if levels are low ,maybe trying Humira every 10 days vs 14. But, would 4 days really make a difference? She didn’t mention weekly…
Also, as bridge therapy while waiting for Humira to work better, is it more common to throw in an oral steroid or try something like Methotrexate?
 

my little penguin

Moderator
Staff member
So when my kiddo was on humira (over 5 years)
First year or so was every 2 weeks
Then he developed juvenile arthritis so
Moved humira to every 10 days
Waited added methotrexate for peripheral joints inflamed
Then added Celebrex as well
After a year or so
Moved humira to every 7 days
Then another year or moved to every 5 days
We squeaked another year out of that so ….
5 plus years on humira

so most don’t jump to every 2 weeks to every 7 days is my point

mtx takes 12 weeks to be effective so not a true bridge
It just boost humira by lower the inflammation humira has to fight
Immediate relief is from formula only and/or oral steroids
While weaning off steriods the mtx is started with the higher frequency of humira typically …
Or just humira
Depends on how aggressive the docs treatment plans
 

Maya142

Moderator
Staff member
My older daughter went from Humira every 14 days (which helped some, but not enough) to every 7 days and that really helped her. She was already on MTX though. She was put on a low dose of oral steroids while we waited for Humira to kick in.

My younger one went from Humira every 14 days (which didn't help enough, if at all) to every 10 days (helped a little) to every 7 days (helped more), then added MTX. Humira + MTX worked like magic for her, though it did take 6 months to work. In hindsight, I'm not sure why we stuck to it so long, perhaps because there were fewer biologics around back then, but I'm so glad we did because at every 7 days, with MTX, it made a huge difference for her - it was really incredible. Later, she moved to every 6 days.

At the time (this was more than 10 years ago), the Humira levels test was not available, so we just went by symptoms.

MTX could definitely help but as said above, it's not really a bridge - more of an add-on therapy. For a bridge, GIs usually use steroids or EEN. There are pros and cons to both. EEN is tougher for kids to do but it actually heals the bowel better. Steroids are easier to take, but come with all sorts of side effects.

Now many GIs will allow a small amount of food with formula - so like 90% formula and 10% food or 85%/15% formula/food - to make it easier for the kiddo. Other docs are stricter and insist on 100% formula, usually for 6-8weeks, though it can be used for longer. Some kids prefer drinking the formula and others require NG tube feeds.
Good luck!
 
Thank you so much for your response!

For oral steroids, did your GI ever use Uceris (Budesonide), or was it always Prednisone?
My son has been on Prednisone once at the very beginning, but it’s the only steroid his GI has mentioned. As I’ve been reading throughout the forum, some have said Budesonide has helped and it’s a bit milder on the side effects vs Prednisone. I wonder if it’s worth pushing Budesonide, or is there a reason Prednisone seems to be the go to?
 

crohnsinct

Well-known member
Generally to induce a remission the pediatric GI’s will go with prednisone over budesonide because it has a higher success rate.
As I mentioned in one of your other threads my older daughter had trouble getting Remicade to get hold of the disease even though she was at max dose and every 4 weeks. She did 6 weeks of EEN and since EEN brings down inflammation but also heals the mucosa, she got to a real good remission and the Remicade was able to hold it.

That level is low for Humira so moving to every week or even every 10 days might help. The addition of mtx could also help. But it also depends on what the antibodies are.

One other thing pediatric docs have found is that kids with active inflammation and their high metabolisms need a much higher trough level than adults. Inflammation alone sops up the drug and you actually end up pooping a lot of it out. So while a level of 5 is the published level for Remicade my daughters’ Docs shoot for a level greater than 10 when inflammation is present. Then when in remission you could start to cut back a little.

Good luck and Keep us posted
 
Generally to induce a remission the pediatric GI’s will go with prednisone over budesonide because it has a higher success rate.
As I mentioned in one of your other threads my older daughter had trouble getting Remicade to get hold of the disease even though she was at max dose and every 4 weeks. She did 6 weeks of EEN and since EEN brings down inflammation but also heals the mucosa, she got to a real good remission and the Remicade was able to hold it.

That level is low for Humira so moving to every week or even every 10 days might help. The addition of mtx could also help. But it also depends on what the antibodies are.

One other thing pediatric docs have found is that kids with active inflammation and their high metabolisms need a much higher trough level than adults. Inflammation alone sops up the drug and you actually end up pooping a lot of it out. So while a level of 5 is the published level for Remicade my daughters’ Docs shoot for a level greater than 10 when inflammation is present. Then when in remission you could start to cut back a little.

Good luck and Keep us posted
Thank you again for your response! This really makes a lot of sense.
My son recently started Uceris foam. Would that be considered a “bridge therapy” to induce remission and help the Humira? Or maybe it wouldn’t be considered bridge therapy since it only reaches up to the Sigmoid colon. I assume only the oral steroid would be able considered bridge therapy to induce remission, rather than topical (rectal) steroids, correct?
 
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